FDA Ordered to Reexamine GE Salmon

A California federal court has ordered the U.S. Food and Drug Administration (FDA) to conduct an assessment on the effects that could ensue if genetically engineered (GE) salmon escaped aquaculture farms and established themselves in the wild. Inst. for Fisheries Resources v. FDA, No. 16-1574 (N.D. Cal., entered November 5, 2020). The court found that the agency did not “meaningfully analyze what might happen to normal salmon in the event the engineered salmon did survive and establish themselves in the wild,” “[e]ven if this scenario was unlikely.” The court noted that FDA knew that AquaBounty was likely to establish additional farms. “Obviously, as the company’s operations grow, so too does the risk of engineered salmon escaping. Thus, it was particularly important at the outset for the agency to conduct a complete assessment of the risks posed by the company’s genetic engineering project, including an assessment of the consequences for normal salmon if the engineered salmon established themselves in the wild.”

“Indeed, we now know that the FDA has subsequently given the company permission to operate a third facility. In approving this facility, the agency relied heavily on the analysis it conducted for the first two facilities, even though that analysis had not meaningfully explained what might happen if the engineered salmon were to establish themselves in the wild. Before starting the country down a road that could well lead to commercial production of genetically engineered fish on a large scale, the FDA should have developed a full understanding—and provided a full explanation—of the potential environmental consequences. The agency is ordered to go back and complete the analysis.”